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NCT07292220
A Study of a Blood Marker in Newborns With Brain Injury Caused by Lack of Oxygen at Birth
trial in Hypoxic-Ischemic Encephalopathy in 20 participants. Not yet recruiting.
14 June 2026
Quick facts
| Lead sponsor | Mustafa Gürkan |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 15 December 2025 |
| Primary completion | 14 June 2026 |
| Estimated completion | 1 August 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Conditions studied
- Hypoxic-Ischemic Encephalopathy — all drugs for Hypoxic-Ischemic Encephalopathy →
Sponsor
Mustafa Gürkan
Who can join
Adults 0 Days to 28 Days, any sex, with Hypoxic-Ischemic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Perinatal asphyxia is a significant health problem with an incidence of 1 to 8 per 1,000 live births and can lead to serious morbidity and mortality during the neonatal period. One of its most severe consequences is hypoxic-ischemic encephalopathy (HIE), a condition that causes irreversible damage to the newborn brain due to hypoxia and ischemia. HIE is one of the leading causes of long-term neurological sequelae. Therapeutic hypothermia initiated within the first six hours after birth has been shown to significantly reduce both mortality and neurodevelopmental impairments associated with HIE. However, biomarkers that can reliably predict individual treatment response or objectively demonstrate the severity of brain injury at an early stage remain limited. Neurofilament light chain (NfL) is a protein found within the cytoskeletal structure of myelinated axons. When axonal injury occurs, NfL is released into the interstitial space and subsequently enters the cerebrospinal fluid and systemic circulation, where it can be measured. Increased NfL levels have been identified in a variety of neurological conditions, including neurodegenerative disorders and traumatic brain injury. Recent findings show that both cerebrospinal fluid and serum/plasma NfL levels are elevated in newborns diagnosed with HIE, supporting its potential role as a biochemical marker of axonal injury. The primary aim of this study is to investigate the time-dependent changes in serum NfL levels in newborns diagnosed with HIE and undergoing therapeutic hypothermia, and to evaluate the relationship between these changes, clinical findings, and neuroimaging results. For this purpose, serum NfL levels were measured at four specific time points: within the first six hours after birth (preferably cord blood), upon reaching the target cooling temperature (approximately 12-24 hours), during the rewarming phase (72-96 hours), and on the day of magnetic resonance imaging (preferably day seven). The results are expected to provide insights into the prognostic utility of NfL in HIE and contribute to determining the optimal timing for clinical sampling. The secondary objective of the study is to compare NfL levels of newborns diagnosed with HIE to those of a control group without HIE, thereby identifying potential cut-off values that may help distinguish between affected and unaffected infants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07292220
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Related trials
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Currently open trials in the same condition.
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- NCT05610085 — A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures · Phase 2 · recruiting
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- NCT03682042 — Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up · NA · recruiting
- NCT05568264 — Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07292220 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mustafa Gürkan
- Last refreshed: 18 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07292220.
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